FDA.reportPublic FDA data

100 ML Flebogamma 50 MG/ML Injection

RxCUI
1809457
RxNorm name
100 ML Flebogamma 50 MG/ML Injection
Display name
100 ML Flebogamma 50 MG/ML Injection
Full name
100 ML Flebogamma 50 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125077Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)Disc2026-08-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2cf22c72-64ac-45be-b7c6-d20340730096Flebogamma 5 % in 100 ML Injection [PSN] · 100 ML immunoglobulin G, human 50 MG/ML Injection [Flebogamma] [SBD] · 100 ML Flebogamma 50 MG/ML Injection [SY] · Flebogamma 5 % per 100 ML Injection [SY] · Flebogamma 5 GM per 100 ML Injection [SY]534These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117